{"success":true,"data":{"pressRelease":{"id":"163519","rtpr_id":"nGNE4yvkF4-20261007","ticker":"VALN","exchange":"NASDAQ","all_tickers":["VALN","VLS"],"title":"REG-Valneva Provides Update on IXCHIQ® in the United Kingdom","author":"Globe Newswire","published_at":"2026-10-07T20:00:00.061Z","article_body":"Lyon (France), October 07, 2026 – Valneva SE\n(https://www.globenewswire.com/Tracker?data=UUC9-xB43pXzTO9jP_hWhXOFzo9SRwlWqfa1t_-Cnv_OaagilH6eOcRLmeFeIhcI9gW4oy8DcYPbJ80ljWBssA==)\n(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today\nannounced that, following a further benefit-risk assessment of IXCHIQ(®) for\ntravelers by the United Kingdom’s (UK) Commission on Human Medicines (CHM),\nthe UK marketing authorization for IXCHIQ(®) has been revoked by the\nMedicines and Healthcare products Regulatory Agency (MHRA). The decision was\nbased on a review of previous safety data and was not associated with any\nnewly identified safety signal. It does not affect the product licenses for\nIXCHIQ(®) in the EU, Canada, Brazil, or other territories where IXCHIQ(®) is\ncurrently marketed.\n\nIXCHIQ(®) was launched in the UK in mid-2025. Due to low sales amongst\ntravelers, Valneva has not actively distributed IXCHIQ(®) in the UK for\nseveral months. As no product currently remains on the UK market, Valneva\nexpects no expense related to product recall and only minimal impact on its\noverall sales revenue going forward.\n\nValneva considers the benefit-risk profile of IXCHIQ(®) favorable when used\nin accordance with the approved indication, contraindications, warnings and\nprecautions. This is further supported by the emerging post-marketing\nevidence, including the ongoing pilot vaccination strategy (PVS)(1) in Brazil,\nwhere more than 61,000 people aged 18-59 years have been vaccinated to date\nwith no new safety concerns identified. Similar safety reviews were concluded\nrecently by the European Medicines Agency (EMA) and by Health Canada, which\nmaintained the marketing authorizations for IXCHIQ(®), with updated product\ninformation. To date, approximately 187,000 doses of IXCHIQ(®) have been\nadministered globally.\n\nWhile the Company disagrees with CHM’s and MHRA’s conclusion, Valneva has\ndecided not to appeal the decision, given its immaterial financial and\ncommercial impact, and in line with the Company’s strategic focus on\nexpanding access to IXCHIQ(®) in endemic territories, where the risk of\nchikungunya virus infection is highest.\n\nAbout Chikungunya\nChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the\nbites of infected Aedes mosquitoes which causes fever, severe joint and muscle\npain, headache, nausea, fatigue and rash. Joint pain is often debilitating and\ncan persist for weeks to years(2). In 2004, the disease began to spread\nquickly, causing large-scale outbreaks around the world. Since the\nre-emergence of the virus, CHIKV has been identified in over 110 countries in\nAsia, Africa, Europe and the Americas3. Between 2013 and 2023, more than 3.7\nmillion cases were reported in the Americas(3) and the economic impact is\nconsidered to be significant. The medical and economic burden is expected to\ngrow with climate change as the mosquito vectors that transmit the disease\ncontinue to spread geographically. As such, the World Health Organization\n(WHO) has highlighted chikungunya as a major public health problem(4).\n\nAbout Valneva SE\nWe are a specialty vaccine company that develops, manufactures, and\ncommercializes prophylactic vaccines for infectious diseases addressing unmet\nmedical needs. We take a highly specialized and targeted approach, applying\nour deep expertise across multiple vaccine modalities, focused on providing\neither first-, best- or only-in-class vaccine solutions.\nWe have a strong track record, having advanced multiple vaccines from early\nR&D to approvals, and currently market three proprietary travel vaccines.\nRevenues from our growing commercial business help fuel the continued\nadvancement of our vaccine pipeline. This includes the only Lyme disease\nvaccine candidate in advanced clinical development, which is partnered with\nPfizer, the world’s most clinically advanced Shigella vaccine candidate, as\nwell as vaccine candidates against other global public health threats. More\ninformation is available at www.valneva.com.\n\n Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelotfontaine@valneva.com  Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com      \n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995 and securities\nlaws in France. These statements may be identified by words such as\n“aims,” “anticipates,” “believes,” “could,” “estimates,”\n“expects,” “forecasts,” “goal,” “intends,” “may,”\n“plans,” “possible,” “potential,” “seeks,” “will” and\nvariations of these words or similar expressions that are intended to identify\nforward-looking statements, although not all forward-looking statements\ncontain these words. All statements other than statements of historical facts\ncontained in this press release are forward-looking statements, including, but\nnot limited to, statements with respect to: the impact of the UK MHRA\nrevocation of the UK marketing authorization for IXCHIQ® on Valneva's\nbusiness, financial condition, and results of operations; Valneva's\nexpectations regarding the financial and commercial impact of the MHRA's\ndecision and its decision not to appeal; the continued validity and status of\nIXCHIQ®'s product licenses and marketing authorizations in the EU, Canada,\nBrazil, and other territories where IXCHIQ® is currently marketed; and\nValneva's assessment of the benefit-risk profile of IXCHIQ® and the outcome\nof related or future regulatory reviews, including by other health\nauthorities. These forward-looking statements are based on Valneva’s\nexpectations and assumptions as of the date of this press release. Each of\nthese forward-looking statements involves risks and uncertainties that could\ncause Valneva’s business, strategy, future results or performance to differ\nmaterially from those expressed or implied by the forward-looking statements.\nMany factors may cause differences between current expectations and actual\nresults, including: Valneva’s success in the commercialization of its\ncommercial products; uncertainties and delays involved in the development and\nmanufacture of vaccines; the potential that success in preclinical testing and\nearlier clinical trials does not ensure that later clinical trials will\ngenerate the same results or otherwise provide adequate data to demonstrate\nthe efficacy and safety of a product candidate; the impacts of macroeconomic\nconditions, including tariffs and other trade policies and uncertainty related\nto such policies; the conflicts in Ukraine, Iran and the Middle East;\nfluctuations in inflation and uncertain credit and financial markets and their\nresulting impacts on Valneva’s business, clinical trials and financial\nposition; unexpected safety or efficacy data observed during preclinical\nstudies or clinical trials; clinical trial site activation or enrollment rates\nthat are lower than expected; Valneva’s ability to realize the benefits of\nits collaboration and license agreements; changes in expected or existing\ncompetition; changes in the regulatory environment; the uncertainties and\ntiming of the regulatory approval process; the impact of the global and\nEuropean credit crisis; the ability to obtain or maintain patent or other\nproprietary intellectual property protection and unexpected litigation or\nother disputes. Other factors that may cause the Company’s actual results to\ndiffer from those expressed or implied in the forward-looking statements in\nthis press release are identified in the section titled “Risk Factors” in\nValneva’s Annual Report on Form 20-F for the year ended December 31, 2025\nfiled with the U.S. Securities and Exchange Commission (“SEC”) and the\nAutorité des marchés financiers (“AMF”) on March 18, 2026, and in other\nfilings made with the SEC and AMF from time to time. Valneva is providing this\ninformation as of the date of this press release and expressly disclaims any\nintention or obligation to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise, except as required by law.\n\n1 Valneva and Instituto Butantan Announce Initiation of a Pilot Vaccination\nCampaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ\n(https://www.globenewswire.com/Tracker?data=UUC9-xB43pXzTO9jP_hWhYPlfQ5fJ95kNioolmjeERYg0Dbs-IkPwafQ5GaWydcPzupSeMNH_-Bp1Oy_PYqQTr6NrAfxpbLUIreVqOgsy41a05mv0AlOBvFF3s0cb7QdaOei7c2VkptrdJksNs5Z7WNDYQbal2MbdldFISAmhnwXc17gEMln2lEewnKMEL6lsONIt2u2aMXPXLw7BRenV0t5P6yAW6uz1YtooDSF9KMGThPdWoBqz8qiX7loQReLNDa_HcgGDwm6aL8FDWzmvROrz_xYWbJbe-EEZfUjx_C-NWBn_0wZwUDIoqjJxH4kcYngXhw2YtIKHr26kPuL_5Bi3SRBoE8tMPNGIRZ7FQnVfhRoBbjmhKF0hsmitFwuGYfywC8NTHIRrC5PVVQZ5nGP1WPFMKlgN97wqe6KAA2PEcXcZWORCB7ilhiMqH5c)(®)\n(https://www.globenewswire.com/Tracker?data=EtZTWhXXrYmzkxtX5wAUTyHgvyihjmc_bV8XRs7iY9_MbUJIXSIEDrMyj-q1eH3vhIvV8QmXD8DLM7989cRWn5Y9IFNK2L-M2H370dAV6LuZ43FjtEyjejzezSZZJkJXJfQlG2zrLkiYKWQpI8HK6RBG5Mmf2_mdQ5suaJpw8qDXPk1KDKLon1kdoa2tKDrS34DBhw0eBrb5BWfnxLx0UU_34PfajhtAToFIPumfQ_jFvjETicvXo2RYLLd9UO0y6dHdfO2E6xUnARnfWvv3-Q==)\n(2)\n(https://www.globenewswire.com/Tracker?data=g44e8KGkoXJte_9w3LcEzlPUD76pJwiXU0cMDskvuDwa48pyHUq16qh_1HA-n8tcyhHLNimzhEoBcOoJuv0EVq1lPN4tvIl1sdmwOOHHaURmEYaHFeZNRyEA2WpUUEzP)\nReemergence of Chikungunya Virus\n(https://www.globenewswire.com/Tracker?data=zHeTZt9QN_JsyxkCbLcP789BUaUCatzTBLfVuTUYPneAKW60GbDdqBg7g5ObMqQ9NPX26Z6xbeCNngZTmTJlF0jWZr6faIy3NS1okO1MTAYPmvobHXRlXEdJQd7IqEETqo0mXVS-VGuZVX1usOcpVoz0yxAMKWmewILCYITTky8=)\n(3)\n(https://www.globenewswire.com/Tracker?data=feQTRmRh_UdWUgzRTPGdavmPx-mUIFnYf-BnmArOKnoNAUPaKSMf3_T3UNtGFJ72Yk-V81ZEP9nd6MLBn0cy7y8qHVZJUr2eg5QO7QOdPX0=)\nVaccine and Therapeutic Options\n(https://www.globenewswire.com/Tracker?data=2WvLcn7sULULXXG_U7e0nHTMBLoYmu-bYQx9d-2cRHCUfpNbRKCVl-f9-XK16P3_oTMKUqyQhMsvNt-dmwHZjSgj_uB-By-okZKjalHKZtIvrJtQ3NZGlQahjFr-23hWcKkxHHR-gk4H5mVJj_YeQQ==)To\n(https://www.globenewswire.com/Tracker?data=MaziyxlGh36orTD6dXQjQHXx7WVhU0Y7r2KRLIbP4Opz1u344YSH_-WIzcY9rv0tgJMpdBg1HTavQowGjyLvXh7Cc_I8T3_YaHLKCK5udVc=)\nControl Chikungunya Virus\n(https://www.globenewswire.com/Tracker?data=jlcZP5eDdp48MEy3un5rx03FOU8C2tMhkLK1sVdBS1m_NvR94vt-MbQQnQDkcq8RDVGBeX5S_g1OVykPKe_S3ETYOc7tw6jkjc2C8l00kLeMh0D1-rc5QyuJvs7Z6NJGj5aTFmjgO6aF2ruv6lg0uw==)\n(4)\n(https://www.globenewswire.com/Tracker?data=GkIWpaCq5_cM7cmWbLVO6wSUIVHkMI3hSBCzRDIHtlOpmv6wo_Ha2olprAseU-gQ72rRPeUXdOa7UARe_NFuyUd-0FWj1pES6fn1_0uKOLWoEfksD8lfzHhx4spPj_e6y58JQQv8E_345cVzJb1t1Q==)\nGeographical expansion of cases of dengue and chikungunya beyond the\nhistorical areas of transmission in the Region of the Americas (who.int)\n(https://www.globenewswire.com/Tracker?data=lMK_OZEzUSGLoJtFScSZDzQo23lE8cunVqXifsoGdlZPIWEcwsxUYVEzMeh6EuCI4ED7T7C2Op3vBNd59nmwWdjaZAPUOLkqgbmhtOEBf-iheg6KJSKhcHdlXICVy6vG3pT7Sinw_XzsfEy6IIVM_JEhHskElZEWrMbB-ytQ5fNX6cnapLC0Bf_WBSOcR7YDkLyRzJHF3pygmkrDdcD23Iv3pzl_t0Afm0itjmeerULk7PUhzg3XdbRU4XNYgVFenpJhwiICMfGVYDGvmkrB1CGaonwGWm9UJVKVtRNEeQXtUEVWRHzIlzyk7FoCwjhOqR1Kfwe4VqyYMu7raV3nkw==)\n\nAttachment\n*     2026_10_07_IXCHIQ_Update_UK_PR_EN\n(https://ml-eu.globenewswire.com/Resource/Download/69c5b07c-d8d3-4b66-a99b-17c48dc142d2)","article_body_html":"","raw_payload":{"data":{"id":"nGNE4yvkF4-20261007","title":"REG-Valneva Provides Update on IXCHIQ® in the United Kingdom","author":"Globe Newswire","ticker":"VALN","created":"2026-10-07T20:00:00.061Z","tickers":["VALN","VLS"],"exchange":"NASDAQ","article_body":"Lyon (France), October 07, 2026 – Valneva SE\n(https://www.globenewswire.com/Tracker?data=UUC9-xB43pXzTO9jP_hWhXOFzo9SRwlWqfa1t_-Cnv_OaagilH6eOcRLmeFeIhcI9gW4oy8DcYPbJ80ljWBssA==)\n(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today\nannounced that, following a further benefit-risk assessment of IXCHIQ(®) for\ntravelers by the United Kingdom’s (UK) Commission on Human Medicines (CHM),\nthe UK marketing authorization for IXCHIQ(®) has been revoked by the\nMedicines and Healthcare products Regulatory Agency (MHRA). The decision was\nbased on a review of previous safety data and was not associated with any\nnewly identified safety signal. It does not affect the product licenses for\nIXCHIQ(®) in the EU, Canada, Brazil, or other territories where IXCHIQ(®) is\ncurrently marketed.\n\nIXCHIQ(®) was launched in the UK in mid-2025. Due to low sales amongst\ntravelers, Valneva has not actively distributed IXCHIQ(®) in the UK for\nseveral months. As no product currently remains on the UK market, Valneva\nexpects no expense related to product recall and only minimal impact on its\noverall sales revenue going forward.\n\nValneva considers the benefit-risk profile of IXCHIQ(®) favorable when used\nin accordance with the approved indication, contraindications, warnings and\nprecautions. This is further supported by the emerging post-marketing\nevidence, including the ongoing pilot vaccination strategy (PVS)(1) in Brazil,\nwhere more than 61,000 people aged 18-59 years have been vaccinated to date\nwith no new safety concerns identified. Similar safety reviews were concluded\nrecently by the European Medicines Agency (EMA) and by Health Canada, which\nmaintained the marketing authorizations for IXCHIQ(®), with updated product\ninformation. To date, approximately 187,000 doses of IXCHIQ(®) have been\nadministered globally.\n\nWhile the Company disagrees with CHM’s and MHRA’s conclusion, Valneva has\ndecided not to appeal the decision, given its immaterial financial and\ncommercial impact, and in line with the Company’s strategic focus on\nexpanding access to IXCHIQ(®) in endemic territories, where the risk of\nchikungunya virus infection is highest.\n\nAbout Chikungunya\nChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the\nbites of infected Aedes mosquitoes which causes fever, severe joint and muscle\npain, headache, nausea, fatigue and rash. Joint pain is often debilitating and\ncan persist for weeks to years(2). In 2004, the disease began to spread\nquickly, causing large-scale outbreaks around the world. Since the\nre-emergence of the virus, CHIKV has been identified in over 110 countries in\nAsia, Africa, Europe and the Americas3. Between 2013 and 2023, more than 3.7\nmillion cases were reported in the Americas(3) and the economic impact is\nconsidered to be significant. The medical and economic burden is expected to\ngrow with climate change as the mosquito vectors that transmit the disease\ncontinue to spread geographically. As such, the World Health Organization\n(WHO) has highlighted chikungunya as a major public health problem(4).\n\nAbout Valneva SE\nWe are a specialty vaccine company that develops, manufactures, and\ncommercializes prophylactic vaccines for infectious diseases addressing unmet\nmedical needs. We take a highly specialized and targeted approach, applying\nour deep expertise across multiple vaccine modalities, focused on providing\neither first-, best- or only-in-class vaccine solutions.\nWe have a strong track record, having advanced multiple vaccines from early\nR&D to approvals, and currently market three proprietary travel vaccines.\nRevenues from our growing commercial business help fuel the continued\nadvancement of our vaccine pipeline. This includes the only Lyme disease\nvaccine candidate in advanced clinical development, which is partnered with\nPfizer, the world’s most clinically advanced Shigella vaccine candidate, as\nwell as vaccine candidates against other global public health threats. More\ninformation is available at www.valneva.com.\n\n Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelotfontaine@valneva.com  Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com      \n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995 and securities\nlaws in France. These statements may be identified by words such as\n“aims,” “anticipates,” “believes,” “could,” “estimates,”\n“expects,” “forecasts,” “goal,” “intends,” “may,”\n“plans,” “possible,” “potential,” “seeks,” “will” and\nvariations of these words or similar expressions that are intended to identify\nforward-looking statements, although not all forward-looking statements\ncontain these words. All statements other than statements of historical facts\ncontained in this press release are forward-looking statements, including, but\nnot limited to, statements with respect to: the impact of the UK MHRA\nrevocation of the UK marketing authorization for IXCHIQ® on Valneva's\nbusiness, financial condition, and results of operations; Valneva's\nexpectations regarding the financial and commercial impact of the MHRA's\ndecision and its decision not to appeal; the continued validity and status of\nIXCHIQ®'s product licenses and marketing authorizations in the EU, Canada,\nBrazil, and other territories where IXCHIQ® is currently marketed; and\nValneva's assessment of the benefit-risk profile of IXCHIQ® and the outcome\nof related or future regulatory reviews, including by other health\nauthorities. These forward-looking statements are based on Valneva’s\nexpectations and assumptions as of the date of this press release. Each of\nthese forward-looking statements involves risks and uncertainties that could\ncause Valneva’s business, strategy, future results or performance to differ\nmaterially from those expressed or implied by the forward-looking statements.\nMany factors may cause differences between current expectations and actual\nresults, including: Valneva’s success in the commercialization of its\ncommercial products; uncertainties and delays involved in the development and\nmanufacture of vaccines; the potential that success in preclinical testing and\nearlier clinical trials does not ensure that later clinical trials will\ngenerate the same results or otherwise provide adequate data to demonstrate\nthe efficacy and safety of a product candidate; the impacts of macroeconomic\nconditions, including tariffs and other trade policies and uncertainty related\nto such policies; the conflicts in Ukraine, Iran and the Middle East;\nfluctuations in inflation and uncertain credit and financial markets and their\nresulting impacts on Valneva’s business, clinical trials and financial\nposition; unexpected safety or efficacy data observed during preclinical\nstudies or clinical trials; clinical trial site activation or enrollment rates\nthat are lower than expected; Valneva’s ability to realize the benefits of\nits collaboration and license agreements; changes in expected or existing\ncompetition; changes in the regulatory environment; the uncertainties and\ntiming of the regulatory approval process; the impact of the global and\nEuropean credit crisis; the ability to obtain or maintain patent or other\nproprietary intellectual property protection and unexpected litigation or\nother disputes. Other factors that may cause the Company’s actual results to\ndiffer from those expressed or implied in the forward-looking statements in\nthis press release are identified in the section titled “Risk Factors” in\nValneva’s Annual Report on Form 20-F for the year ended December 31, 2025\nfiled with the U.S. Securities and Exchange Commission (“SEC”) and the\nAutorité des marchés financiers (“AMF”) on March 18, 2026, and in other\nfilings made with the SEC and AMF from time to time. Valneva is providing this\ninformation as of the date of this press release and expressly disclaims any\nintention or obligation to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise, except as required by law.\n\n1 Valneva and Instituto Butantan Announce Initiation of a Pilot Vaccination\nCampaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ\n(https://www.globenewswire.com/Tracker?data=UUC9-xB43pXzTO9jP_hWhYPlfQ5fJ95kNioolmjeERYg0Dbs-IkPwafQ5GaWydcPzupSeMNH_-Bp1Oy_PYqQTr6NrAfxpbLUIreVqOgsy41a05mv0AlOBvFF3s0cb7QdaOei7c2VkptrdJksNs5Z7WNDYQbal2MbdldFISAmhnwXc17gEMln2lEewnKMEL6lsONIt2u2aMXPXLw7BRenV0t5P6yAW6uz1YtooDSF9KMGThPdWoBqz8qiX7loQReLNDa_HcgGDwm6aL8FDWzmvROrz_xYWbJbe-EEZfUjx_C-NWBn_0wZwUDIoqjJxH4kcYngXhw2YtIKHr26kPuL_5Bi3SRBoE8tMPNGIRZ7FQnVfhRoBbjmhKF0hsmitFwuGYfywC8NTHIRrC5PVVQZ5nGP1WPFMKlgN97wqe6KAA2PEcXcZWORCB7ilhiMqH5c)(®)\n(https://www.globenewswire.com/Tracker?data=EtZTWhXXrYmzkxtX5wAUTyHgvyihjmc_bV8XRs7iY9_MbUJIXSIEDrMyj-q1eH3vhIvV8QmXD8DLM7989cRWn5Y9IFNK2L-M2H370dAV6LuZ43FjtEyjejzezSZZJkJXJfQlG2zrLkiYKWQpI8HK6RBG5Mmf2_mdQ5suaJpw8qDXPk1KDKLon1kdoa2tKDrS34DBhw0eBrb5BWfnxLx0UU_34PfajhtAToFIPumfQ_jFvjETicvXo2RYLLd9UO0y6dHdfO2E6xUnARnfWvv3-Q==)\n(2)\n(https://www.globenewswire.com/Tracker?data=g44e8KGkoXJte_9w3LcEzlPUD76pJwiXU0cMDskvuDwa48pyHUq16qh_1HA-n8tcyhHLNimzhEoBcOoJuv0EVq1lPN4tvIl1sdmwOOHHaURmEYaHFeZNRyEA2WpUUEzP)\nReemergence of Chikungunya Virus\n(https://www.globenewswire.com/Tracker?data=zHeTZt9QN_JsyxkCbLcP789BUaUCatzTBLfVuTUYPneAKW60GbDdqBg7g5ObMqQ9NPX26Z6xbeCNngZTmTJlF0jWZr6faIy3NS1okO1MTAYPmvobHXRlXEdJQd7IqEETqo0mXVS-VGuZVX1usOcpVoz0yxAMKWmewILCYITTky8=)\n(3)\n(https://www.globenewswire.com/Tracker?data=feQTRmRh_UdWUgzRTPGdavmPx-mUIFnYf-BnmArOKnoNAUPaKSMf3_T3UNtGFJ72Yk-V81ZEP9nd6MLBn0cy7y8qHVZJUr2eg5QO7QOdPX0=)\nVaccine and Therapeutic Options\n(https://www.globenewswire.com/Tracker?data=2WvLcn7sULULXXG_U7e0nHTMBLoYmu-bYQx9d-2cRHCUfpNbRKCVl-f9-XK16P3_oTMKUqyQhMsvNt-dmwHZjSgj_uB-By-okZKjalHKZtIvrJtQ3NZGlQahjFr-23hWcKkxHHR-gk4H5mVJj_YeQQ==)To\n(https://www.globenewswire.com/Tracker?data=MaziyxlGh36orTD6dXQjQHXx7WVhU0Y7r2KRLIbP4Opz1u344YSH_-WIzcY9rv0tgJMpdBg1HTavQowGjyLvXh7Cc_I8T3_YaHLKCK5udVc=)\nControl Chikungunya Virus\n(https://www.globenewswire.com/Tracker?data=jlcZP5eDdp48MEy3un5rx03FOU8C2tMhkLK1sVdBS1m_NvR94vt-MbQQnQDkcq8RDVGBeX5S_g1OVykPKe_S3ETYOc7tw6jkjc2C8l00kLeMh0D1-rc5QyuJvs7Z6NJGj5aTFmjgO6aF2ruv6lg0uw==)\n(4)\n(https://www.globenewswire.com/Tracker?data=GkIWpaCq5_cM7cmWbLVO6wSUIVHkMI3hSBCzRDIHtlOpmv6wo_Ha2olprAseU-gQ72rRPeUXdOa7UARe_NFuyUd-0FWj1pES6fn1_0uKOLWoEfksD8lfzHhx4spPj_e6y58JQQv8E_345cVzJb1t1Q==)\nGeographical expansion of cases of dengue and chikungunya beyond the\nhistorical areas of transmission in the Region of the Americas (who.int)\n(https://www.globenewswire.com/Tracker?data=lMK_OZEzUSGLoJtFScSZDzQo23lE8cunVqXifsoGdlZPIWEcwsxUYVEzMeh6EuCI4ED7T7C2Op3vBNd59nmwWdjaZAPUOLkqgbmhtOEBf-iheg6KJSKhcHdlXICVy6vG3pT7Sinw_XzsfEy6IIVM_JEhHskElZEWrMbB-ytQ5fNX6cnapLC0Bf_WBSOcR7YDkLyRzJHF3pygmkrDdcD23Iv3pzl_t0Afm0itjmeerULk7PUhzg3XdbRU4XNYgVFenpJhwiICMfGVYDGvmkrB1CGaonwGWm9UJVKVtRNEeQXtUEVWRHzIlzyk7FoCwjhOqR1Kfwe4VqyYMu7raV3nkw==)\n\nAttachment\n*     2026_10_07_IXCHIQ_Update_UK_PR_EN\n(https://ml-eu.globenewswire.com/Resource/Download/69c5b07c-d8d3-4b66-a99b-17c48dc142d2)"},"type":"article","timestamp":"2026-10-07T20:00:00.17226078Z","server_sent_at_ms":1791403200172},"received_at":"2026-10-07T20:00:00.313Z","source_url":null},"analysis":{"id":"151976","press_release_id":"163519","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["UK marketing authorization revoked on benefit-risk grounds despite no new safety signal","first Western regulator revocation for IXCHIQ; warrants monitoring whether other regulators follow","UK commercial traction was weak enough that distribution had already been halted"],"eventType":"regulatory","narrative":"Valneva announced that the UK MHRA revoked the marketing authorization for its chikungunya vaccine IXCHIQ following a further benefit-risk assessment by the Commission on Human Medicines.\n\nThe decision was based on a review of previous safety data with no newly identified safety signal, and does not affect licenses in the EU, Canada, Brazil, or other territories. EMA and Health Canada recently maintained IXCHIQ authorizations with updated product information.\n\nFinancial impact appears limited: Valneva stopped actively distributing IXCHIQ in the UK months ago due to low traveler sales, expects no recall expense, and will not appeal. Supportive post-marketing data include more than 61,000 people vaccinated in Brazil's pilot campaign with no new safety concerns.","sentiment":"bearish","agentHooks":{"shouldPost":false,"suggestedAngle":"MHRA pulls IXCHIQ in the UK, but company says financial impact is immaterial as other major markets hold."},"keyFigures":{"drugName":"IXCHIQ","customDimensions":{"brazil_pvs_vaccinated":"more than 61,000","doses_administered_globally":"approximately 187,000"}},"quotedText":"the UK marketing authorization for IXCHIQ(®) has been revoked by the Medicines and Healthcare products Regulatory Agency (MHRA)","namedEntities":{"people":[{"name":"Laetitia Bachelot-Fontaine","role":"VP, Global Communications and European Investor Relations, Valneva"},{"name":"Joshua Drumm","role":"VP, Global Investor Relations, Valneva"}],"products":["IXCHIQ"],"companies":[{"name":"Valneva SE","ticker":"VALN","relationship":"filer"},{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)","relationship":"regulator"},{"name":"Commission on Human Medicines (CHM)","relationship":"regulator"},{"name":"European Medicines Agency (EMA)","relationship":"regulator"},{"name":"Health Canada","relationship":"regulator"},{"name":"Pfizer","relationship":"partner"},{"name":"Instituto Butantan","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"The MHRA revoked the UK marketing authorization for IXCHIQ, but the company had already halted UK distribution due to low sales, expects no recall expense, and claims only minimal revenue impact. Licenses in the EU, Canada, and Brazil remain intact."},"tickerRelevance":{"others":[],"primary":"VALN"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap-biotech","eventGravity":"regulatory-revocation-single-market","financialImpactClaimed":"immaterial","otherMarketsUnaffected":true}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bearish","material_impact_score":2,"narrative":"Valneva announced that the UK MHRA revoked the marketing authorization for its chikungunya vaccine IXCHIQ following a further benefit-risk assessment by the Commission on Human Medicines.\n\nThe decision was based on a review of previous safety data with no newly identified safety signal, and does not affect licenses in the EU, Canada, Brazil, or other territories. EMA and Health Canada recently maintained IXCHIQ authorizations with updated product information.\n\nFinancial impact appears limited: Valneva stopped actively distributing IXCHIQ in the UK months ago due to low traveler sales, expects no recall expense, and will not appeal. Supportive post-marketing data include more than 61,000 people vaccinated in Brazil's pilot campaign with no new safety concerns.","key_figures":{"drugName":"IXCHIQ","customDimensions":{"brazil_pvs_vaccinated":"more than 61,000","doses_administered_globally":"approximately 187,000"}},"named_entities":{"people":[{"name":"Laetitia Bachelot-Fontaine","role":"VP, Global Communications and European Investor Relations, Valneva"},{"name":"Joshua Drumm","role":"VP, Global Investor Relations, Valneva"}],"products":["IXCHIQ"],"companies":[{"name":"Valneva SE","ticker":"VALN","relationship":"filer"},{"name":"Medicines and Healthcare products Regulatory Agency (MHRA)","relationship":"regulator"},{"name":"Commission on Human Medicines (CHM)","relationship":"regulator"},{"name":"European Medicines Agency (EMA)","relationship":"regulator"},{"name":"Health Canada","relationship":"regulator"},{"name":"Pfizer","relationship":"partner"},{"name":"Instituto Butantan","relationship":"partner"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-07T20:00:06.577Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small-cap-biotech","eventGravity":"regulatory-revocation-single-market","financialImpactClaimed":"immaterial","otherMarketsUnaffected":true}},"durationMs":6232,"modelName":"glm-5.3-flashx"}}